Clinical Laboratory Scientist - Planet Pharma

4-month initial contract

Sun-Wed or Sun- Thur- schedule

Must be available on some weekends- will alternate with other staff

Must be CLS CA Licensed

Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements.

SUMMARY:

The Clinical Laboratory Scientist I is responsible for performing laboratory testing, recording and reviewing test results, preparing and labeling blood components.

Essential Responsibilities:

•Perform all tasks in compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and other regulatory requirements.

•Properly use the Blood Product Information System, as well as authorize and perform system overrides as needed and within scope of authority and ensure to escalate system problems as/if encountered, to management.

•Accurately perform testing of blood products and donor samples (i.e., hematology counts (CBC), and pH).

•Accurately record, interpret, and report test results. Ability to recognize and appropriately handle unacceptable test results.

•Verify acceptability of blood samples.

•Prepare and pack blood samples for send-out testing.

•Properly use laboratory equipment.

•Properly perform, and complete comprehension of, quality control and preventative maintenance of laboratory equipment.

•Maintain laboratory records; adhere to proper flow of paperwork.

•Perform blood component preparation from whole blood and apheresis collections.

•Label blood products.

•Perform quarantine, destruction, and release of blood products.

•Prepare, perform and report proficiency testing. (i.e. CAP)

•Accurately report errors.

•Evaluate blood component QC testing.

•Review and/or order and maintain proper inventory levels of laboratory supplies/reagents.

•Prepare laboratory statistical reports.

•Identify and troubleshoot problems encountered in assigned tasks and properly document corrective actions. Confer with managerial staff for resolution of problems, if necessary.

•Inform supervisory staff of any recommendations for process improvement.

•Read and understand company and industry manuals and compliance standards, including SOPs, FDA requirements (cGMPs) and AABB regulations.

•Know and follow safety rules relative to area(s) of responsibility.

•Present a professional image to customers, internal and external.

•Revision of company SOP’s as required.

•Other duties as assigned.

Supervisory Responsibilities:

This position has no direct supervisory responsibility

Qualifications:

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

•Discretion in handling confidential and sensitive matters

•Meets department quality standards.

•Good time management skills with the ability to complete assignments within established timelines.

Education, Experience, and Licensure:

•Bachelor’s degree in biological, physical, or chemical sciences or medical technology is preferred

•At least 1 years of previous CLS working experience preferred

•Current state CLS Generalist license required.

•MT (ASCP), preferred.

•Blood donor center or transfusion service experience is a plus.

Technical Skills:

•Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.

•Ability to quickly learn new software programs as needed.

Language Skills:

Must have a good command of the English language and be able to communicate clearly and concisely in both written and verbal format.

Mathematical Skills:

Must be able to analyze and present quantitative data. Able to accurately compute basic mathematical equations such as addition, subtraction, division, multiplication, and percentages.

Reasoning Ability:

Must be able to analyze and interpret data relating to various projects and resolve issues and problems that arise.

•Must be able to resolve issues of a general and routine nature and exercise appropriate judgment to escalate issues to senior management.

•Must be able to effectively prioritize routine and nonroutine work assignments to ensure goals and timelines are met.

Physical Demands and Work Environment:

The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.

•Work is conducted in the Shipping, Laboratory, Donor Center, or standard office environment. Temperatures are regulated by facilities management and are not within the direct control of the individual or company. Most work is conducted in open areas with associated distractions such as noise from telephones, keyboards, machines, doorbells, and talking.

•Work performed in the Shipping, Laboratory, and Donor Center is done primarily while standing (6 to 8 hours a day). Work performed in the office environment is performed primarily while sitting (6 to 8 hours a day). All work environments utilize keyboards, gaze at a monitor(s), utilize hands to grasp, reach, and hold. The employee must frequently lift or move up to 10 pounds over their shoulder and occasionally lift or move up to 50 pounds. Staff who works in the Shipping / Logistics or Warehouse departments may be required to lift or move more than 50 pounds while using proper safety equipment.

•Exposure to standard chemicals used in an office environment is expected. Additional exposure to Shipping, Laboratory, and Donor Room staff includes exposure to water, chemicals, bloodborne pathogens, waste, infectious material, dry ice, and liquid nitrogen. Refer to the Safety Data Sheets for a complete list.

•Staff must wear Personal Protective Equipment (PPE) when performing tasks that may expose to bloodborne pathogens, waste, infectious material, dry ice, and liquid nitrogen or as required per policy.